Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
73/2007
Study information
Scientific title
Acronym
Study hypothesis
1. Open mesh repair hernia surgery is better than suture repair hernia surgery of incision hernia treatment
2. The recurrence rate using suture hernia repair technique is much higher than mesh repair technique
3. The recovering time to the normal physical activity after surgery is faster, quality of life is better using mesh repair with sublay technique than mesh repair with onlay technique or suture repair technique of the incision hernia treatment
Ethics approval
Ethics approval received from Kaunas Biomedical Research Ethics Committee on the 5th June 2007 (ref: BE-2-41).
Study design
Blinded, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hernia
Intervention
Three groups:
1. Keel technique
2. Onlay technique
3. Sublay technique
The follow up period is 2 weeks, 1, 3, 6 and 12 months after surgery. Surgery, blood gas analysis and intra-abdominal pressure investigation before and after operation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Recurrence rate, measured at 2 weeks, 1, 3, 6 and 12 months after surgery
2. Quality of life, measured using the 36-item Short Form health survey version 2 (SF-36 v2)at 2 weeks, 1, 3, 6 and 12 months after surgery
Secondary outcome measures
1. Postoperative complications, measured at 2 weeks, 1, 3, 6 and 12 months after surgery
2. Change of the blood gas and intra-abdominal pressure, measured before and after surgery
3. Recovering time to the normal physical activity after surgery, measured at 2 weeks, 1, 3, 6 and 12 months after surgery
Overall trial start date
01/07/2007
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
Participant inclusion criteria
All 18 - 80 years old patients with incision hernia, who will be operated and agree to participate in this clinical trial.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 patients in each group, 150 patients in all
Participant exclusion criteria
1. Patients older than 80 years
2. Incarcerated incision hernia
3. Mental patients with incision hernia
4. Pregnant women with incision hernia
5. Patients with incision hernia do not agree to participate in this clinical trial
Recruitment start date
01/07/2007
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Lithuania
Trial participating centre
Eiveniu str. 2
Kaunas
LT50009
Lithuania
Sponsor information
Organisation
Kaunas Medical University Hospital (Lithuania) - Department of Surgery
Sponsor details
Eiveniu str. 2
Kaunas
LT50009
Lithuania
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Kaunas Medical University Hospital (Lithuania) - Department of Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary